UNIVERSITY OF MICHIGAN CONSENT FOR COMPASSIONATE USE OF AN FDA INVESTIGATIONAL AGENT

1. INFORMATION ABOUT COMPASSIONATE USE TREATMENTS AND THIS DOCUMENT We have determined that you have [NAME OF CONDITION]. We believe that [SPECIFY NAME OF DRUG/DEVICE] may help you. There is currently no other treatment that we believe would be as helpful.

[SPECIFY DRUG/DEVICE] is an investigational agent. An investigational agent is one that researchers are still studying to find out whether it’s safe and effective. Because this [DRUG/DEVICE] is investigational, the Food and Drug Administration (FDA) has not yet approved it for general use.

The purpose of this form is to help you understand how [SPECIFY NAME OF DRUG/DEVICE] works and to give you an opportunity to decide whether you want us to use it to treat you. We may also give you information from the company that supplies the [DRUG/DEVICE].

[Insert conflict of interest information here if applicable (e.g., “The University of Michigan owns shares in the company that makes [SPECIFY NAME OF DRUG/DEVICE] and may profit from its use”).]

Before you sign this form, be sure you understand how [SPECIFY NAME OF DRUG/DEVICE] relates to your condition, as well as the risks and possible benefits of using it.

2. SPECIFIC INFORMATION ABOUT THE TREATMENT 2.1 Name of Doctor Providing Treatment with the [DRUG/DEVICE]:

2.2 Name of the [DRUG/DEVICE]:

2.3 Title of the Compassionate Use project:

2.4 Project Number: HUM

2.5 Why is this [DRUG/DEVICE] being recommended?

Page 1 of 5 Consent Subtitle: ______Consent Version: ______[SPECIFY NAME OF DRUG/DEVICE] is used to treat [NAME OF CONDITION] by [DESCRIBE WHAT THE DRUG/DEVICE DOES—e.g., “connecting the two chambers of the heart for better blood flow”].

2.6 What is usually done for patients who have this type of disease or condition? Standard treatments for [NAME OF CONDITION] include [LIST AND DESCRIBE STANDARD TREATMENTS]. We will be glad to talk to you about your other treatment options.

3. COSTS ASSOCIATED WITH THIS TREATMENT

[Select one of the following for 3.1 then delete the other option as well as all bracketed instructions:]

3.1 [For investigational drug or device if patient will be responsible for ALL costs:] You or your insurance will be responsible for the cost of all care associated with the procedure[s] and the [DRUG/DEVICE] itself. This includes the cost of treatment if the [DRUG/DEVICE] makes you sick or causes you injury. It is possible that your insurance will not pay for the cost of the [include as applicable: drug, device, procedure to implant the device] because the [DRUG/DEVICE] is considered investigational. If that occurs, you will be responsible for all costs, and these costs may be substantial.

3.1 [For investigational drug or device if sponsor is providing free drug/device:] The [DRUG/DEVICE] will be provided to you at no cost. You or your insurance company will be responsible for the remaining costs related to this treatment, including the cost of treatment if the [DRUG/DEVICE] makes you sick or causes you injury. You will be responsible for any costs your insurance does not cover. If you have any questions about these costs, or what out-of-pocket expenses you may be responsible for, contact your insurance company.

3.2 By signing this form, you do not give up your right to seek payment if you are harmed as a result of receiving this treatment.

4. HOW INFORMATION ABOUT YOU WILL BE SHARED 4.1 If you give us permission to use [SPECIFY NAME OF DRUG/DEVICE], we will give the following information about you to [COMPANY NAME], which is the manufacturer or supplier of the [DRUG/DEVICE]:

4.2 We may provide the Institutional Review Board of the University of Michigan Medical School (IRBMED) with the following kind(s) of information:  Any problems that occur when you are treated with this [DRUG/DEVICE].  [ANY OTHER INFORMATION THAT APPLIES] We usually provide this information to IRBMED with a code instead of using your name. In some instances, however, IRBMED may need to review your medical records and may request your name from your doctor to access your records.

4.3 University, Food and Drug Administration (FDA), and/or other government officials may also need the information to make sure that the [DRUG/DEVICE] is used in a safe and proper manner.

For more information about our use and disclosure of protected health information, please refer to the University of Michigan Health System’s Notice of Privacy Practices. You should already have received a copy. You may also find this notice online, at http://www.med.umich.edu/hipaa/npp.htm.

5. RISKS AND BENEFITS 5.1 What are the risks of being treated with this [DRUG/DEVICE]?

5.2 What are the possible benefits of being treated with this [DRUG/DEVICE]?

5.3 You are free to stop the using this [DRUG/DEVICE] at any time, and your treatment with it is voluntary. Before stopping, you should discuss your choice with your doctor, as stopping its use may pose additional risks to you that your doctor may need to manage. If you stop treatment before it is finished, there will be no penalty or loss of benefits to which you may otherwise be entitled. If you decide to stop treatment before it is finished, please tell one of the persons listed in Section 6 “Contact Information” (below).

6. CONTACT INFORMATION 6.1 Who can I contact about this treatment? Please contact the doctor listed below to:  Obtain more information about the [DRUG/DEVICE]  Ask a question about the [DRUG/DEVICE]  Talk about treatment-related costs to you or your health plan  Report an illness, injury, or other problem (you may also need to tell your other doctors)  Stop the treatment before it is finished  Express a concern

Page 3 of 5 Consent Subtitle: ______Consent Version: ______Doctor Overseeing Treatment: Mailing Address: Telephone:

You may also express a concern about this use of the investigational [DRUG/DEVICE] by contacting the Institutional Review Board listed below:

University of Michigan Medical School Institutional Review Board (IRBMED) 2800 Plymouth Road Building 520, Room 3214 Ann Arbor, MI 48109-2800 Telephone: 734-763-4768 (For international calls: US Country Code: 001) Fax: 734-763-1234 e-mail: [email protected]

If you are concerned about a possible violation of your privacy or concerned about use of an investigational [DRUG/DEVICE], you may contact the University of Michigan Health System Compliance Help Line at 1-866-990-0111.

When you call or write about a concern, please provide as much information as possible, including the name of the doctor providing treatment with the [DRUG/DEVICE], the IRBMED HUM number (at the top of this form), and details about the problem. This will help University officials to look into your concern. When reporting a concern, you do not have to give your name unless you want to.

7. RECORD OF INFORMATION PROVIDED 7.1 What documents will I receive?  This consent form (Note: In addition to the copy you receive, copies of this document will be stored in a separate confidential file and may be entered into your regular University of Michigan medical record.)

 Other (specify): 8. SIGNATURE

If patient is not able to give consent for use of this investigational agent, use the section on the next page to obtain permission from a legally authorized representative or a parent. Page 5 of 5 Consent Subtitle: ______Consent Version: ______